Vape Royalty, LLC – FDA Warning Letter, Apr 27, 2020

The FDA Center for Tobacco Products issued a Warning Letter to the operator of vaperoyalty.com after reviewing their website and identifying an e-liquid product, "Candy King Batch," offered for sale or distribution in the United States. This product is deemed a tobacco product under section 201(rr) of the FD&C Act and is subject to FDA jurisdiction.

The primary violation is that "Candy King Batch" is a "new tobacco product" that was not commercially marketed in the U.S. as of February 15, 2007, and lacks the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the product is adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because required notice or information was not provided.

The FDA expressed particular concern that the "Candy King Batch" e-liquid packaging imitates "Sour Patch Kids" candy, which is typically marketed to children, raising concerns about youth appeal and use of ENDS products.

The letter requires the recipient to promptly correct all violations and submit a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and advertising, and a plan for future compliance. Failure to comply may result in civil money penalties, seizure, and/or injunction.